Portal Hypertension Clinical Trial
Official title:
Safety and Efficacy of Splenic Artery Embolization to Treat Symptomatic Portal
Verified date | March 2022 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary purpose of this study is to evaluate the safety and efficacy of partial splenic artery embolization in the treatment of symptomatic portal vein hypertension. A secondary aim is to evaluate the relative efficacy of two separate splenic artery embolization techniques, coiling versus particle embolization of the spleen. These two methods will be compared to standard medical management which consist of pain management and fluid draining.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 1, 2021 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 70 Years |
Eligibility | Inclusion Criteria: - • Patients who are between 22-70 years of age. - Patient must have portal hypertension; as defined by: refractory ascites or unilateral right sided pleural effusions with concomitant liver cirrhosis and splenomegaly (spleen > 11 cm on CT or US). - Medically refractive/intolerant, ascites or unilateral right sided pleural effusions consistent with hepatic hydrothorax. Medically refractive defined as those with persistent need for paracentesis or thoracentesis despite maximal doses of diuretics (400 mg spironolactone and 160 mg furosemide per day) or those who are intolerant of furosemide (develop azotemia, electrolyte imbalance, encephalopathy or renal failure) or spironolactone (develop gynecomastia, decreased libido, and hyperkalemia). - Patients will need to meet one or more of the following requirements: - MELD >18 but <35 - Anatomic variation making TIPS impossible/difficult - Previous failed attempt to place TIPS - Unwilling to undergo TIPS - History of severe hepatic encephalopathy - Thrombosis of the hepatic veins - Willing and able to provide informed consent Exclusion Criteria: - Patients < 22 and >70 years of age - Patients with CLDQ score of >6 or <2 - Patients with a weight >400 pounds - Patients with primary or secondary splenic cancer - Currently pregnant - Current systemic infection - Patients who have undergone prior splenectomy or other splenic surgery - Patients who have previously undergone splenic artery embolization for any reason (likely reasons would be trauma or thrombocytopenia) - Patients with splenic vascular anatomy that would increase the risk of non-target embolization. - Patients who have a INR or platelet count which are not correctable to <1.8 and >35,000 respectively - Anaphylaxis to intravenous contrast. - Patients diagnosed with Budd-Chiari Syndrome (This will be assessed on pre-intervention CTA) |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Quality of Life | Administration of the Chronic Liver Disease Questionnaire (CLDQ) | pre-procedural (baseline) and at 1, 3, 6, and 12 month follow-up visits | |
Primary | Incidence of Treatment Adverse Events | Evaluation of all procedure-related adverse events (PRAE) and serious adverse events (SAE) | Patients will be evaluated for adverse events post procedural at 72hrs, 1 week, and 1, 3, 6, and 12 months | |
Secondary | Ascites Production | Fluid production | pre-procedural and at 1, 3, and 6 months | |
Secondary | Splenic Size | Changes in size of spleen as indicated by MRI or CT | pre-procedural and at 1,3,6 and 12 months | |
Secondary | Portal Vein Velocity | Changes in flow volume and velocity as evidenced by ultra sound | pre-procedural and at 1, 6 and 12 months |
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